Concerns about broken vena cava filters resurface as a Japanese study finds a high rate of fracture for Cordis Corp.'s TrapEase permanent implant.
A new study reported a high fracture rate among permanent inferior vena cava filters made by Cordis Corp., a device-making arm of Johnson & Johnson (NYSE:JNJ).
In a Japanese study of 20 patients with Cordis' TrapEase IVC filter, the devices fractured in half the patients at 50 months.
The study adds to concerns that surfaced last year when the FDA recommended that physicians consider removing retrievable inferior vena cava filters after logging 921 reports of "adverse events" related to the devices.
The federal watchdog agency warned that certain IVC filters could fracture, causing pieces of the device to travel through the bloodstream to other parts of the body.
Doctors place the device in the inferior vena cava, the main vein that brings blood back to the heart from the lower half of the body, to keep blood clots from traveling to the lungs and causing pulmonary embolisms. The implant treats patients with venous thromboembolism who have not responded to or cannot take anti-clotting medications.
There are two types of IVC filters, a permanent implant and a "retrievable" device meant for temporary use. The FDA said many of the 921 events reported appeared to be related to "a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of [PE] has subsided."
Edwards Lifesciences reports 3rd-quarter sales and earnings growth in excess of 20% and raises its...
A federal jury in Texas reportedly clears Johnson & Johnson's DePuy Pinnacle hip implant in the...
Federal auditors say the FDA needs to ramp up its cybersecurity efforts in order to deter hackers.
ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter.